Ziihera (zanidatamab-hrii) - (HERIZON-GEA-01)

May 6, 2026: BeOne Medicines Ltd. (NASDAQ: ONC; HKEX: 06160; SSE: 688235) reported Q1 2026 financial results and provided regulatory/clinical updates. Total revenue was $1.51B (+35% YoY), driven by BRUKINSA (zanubrutinib) global sales of $1.1B (+38%; U.S. $761M, +35%). TEVIMBRA (tislelizumab) sales were $206M (+20%); Amgen in-licensed products were $142M (+25%). GAAP net income was $227M (vs $1.3M prior year), and free cash flow was $161M. Full-year 2026 revenue guidance was raised to $6.3–$6.5B.

Regulatory/filing catalysts:

• BRUKINSA: Orphan Drug Designation in Japan for adult R/R marginal zone lymphoma (MZL); Japan NDA submitted for R/R MZL and a tablet formulation.
• TEVIMBRA: FDA accepted a Priority Review sBLA for 1L HER2-positive gastroesophageal adenocarcinoma (GEA) with ZIIHERA (zanidatamab) + chemotherapy (HERIZON-GEA-01 showed OS improvement vs trastuzumab + chemo). China CDE also accepted an sBLA for the same combo.
• ZIIHERA: China CDE accepted an sBLA for 1L HER2-positive GEA with chemotherapy, with or without TEVIMBRA.

Pipeline milestones:

• BGB-16673 (BTK CDAC): Phase 2 cohorts initiated in R/R MZL and Richter’s transformation.
• BGB-B2033 (GPC3x41BB): FDA Orphan Drug Designation for HCC; potentially registrational HCC study initiated.
• BG-C0979 (ADAM9 ADC), BG-A3004 (KLRG1 mAb): first-in-human studies initiated.
• Exclusive option signed with Huahui Health for worldwide rights to HH160 (BON-110), a PD-1/VEGF-A/CTLA-4 trispecific.

Upcoming catalysts (as stated): BRUKINSA Phase 3 MANGROVE interim analysis (1H 2026); sonrotoclax FDA action for R/R MCL NDA monotherapy (1H 2026); FDA action for 1L HER2+ GEA TEVIMBRA+ZIIHERA (2H 2026); TEVIMBRA China action for 1L HER2+ GEA (1H 2027); multiple Phase 3 initiations and potential accelerated approval submission (2H 2026).